Dialysis catheter assembly

ABSTRACT

A catheter assembly includes an elongated main body defining two or more longitudinal lumens including distally positioned openings. One or more side-ports are defined in the main body communicating with at least one of the two or more longitudinal lumens. The catheter assembly also includes an inflatable balloon disposed around a portion of the main body. The inflatable balloon includes a distal end disposed substantially adjacent to a proximal side of one or more side-ports. The inflatable balloon in the inflated state is adapted to extend at partially over the one or more side-ports.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 13/165,097, filed Jun. 21, 2011, the entirecontents of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to catheters for use in medicalapplications and, more particularly, to a dialysis catheter assemblyincluding an inflatable balloon.

BACKGROUND

Catheters are flexible medical instruments for use in the withdrawal andintroduction of fluids to and from body cavities, ducts, and vessels.Catheters have particular application in hemodialysis procedures, inwhich blood is withdrawn from a blood vessel for treatment andsubsequently returned to the blood vessel for circulation through apatient's body. The use of long-term chronic catheters in the treatmentof patients requiring dialysis is common due to the necessity ofrepeated dialysis treatments.

Hemodialysis catheters with multiple lumens typically permitbi-directional fluid flow within the catheter, whereby one lumen isdedicated to the withdrawal of fluid from a vessel, and at least oneother lumen is dedicated to the return of fluid to the vessel.Generally, the lumen through which fluid is withdrawn is referred to asthe “aspiration” lumen, and the lumen through which fluid is returned isreferred to as the “perfusion” lumen. Triple-lumen catheters may alsoenable the passage of other fluids including medicants in addition tothe general use of dialysis. Some multiple-lumen catheters may include aside-port formed in a wall portion of the catheter.

In a hemodialysis procedure, after placement of a multiple-lumencatheter in a patient, blood is withdrawn from the patient through theaspiration lumen of the catheter and/or the side-port associated withthe aspiration lumen, and is directed to a hemodialysis unit. Thedialyzed blood is then returned to the patient's circulation through theperfusion lumen of the catheter and/or any side-port associated with theperfusion lumen.

Various tissue may begin to adhere to the exterior surface of thecatheter after a period of time. These various tissues may impede theperformance of the dialysis catheter by disrupting the flow of bloodaround the catheter or blocking the side-ports or distal opening in thelumens. For example, central vein stenosis and occlusion is commonlyassociated with placement of peripherally-inserted central venouscatheters. More specifically, the trauma and inflammation related tocatheter placement, such as denudation of the endothelium of the vesselsurrounding the catheter, may result in microthrombi formation, intimalhyperplasia and fibrotic response which, over time, narrows the vesselsignificantly and can close off blood flow around the dialysis catheter.Similarly, thrombus or fibrin sheath may begin to adhere to the exteriorof the catheter and eventually obscure any side-ports or distalopenings.

Central vein stenosis, thrombus, and fibrin sheath adhesion around thecatheter may result in flow disturbance or obstruction of the catheterports and may affect the delivery of dialysis. Such flow disruption orobstruction diminishes the useful life of the catheter and may requiremore frequent removal and replacement of the catheter to restore flow.Improved catheter devices are needed to minimize the occurrence ofcentral vein stenosis, thrombus or fibrin sheath adhesion to avoidhemodialysis access failure and other complications.

SUMMARY

The present invention provides a catheter having a inflatable balloon ona portion of an outer surface thereof configured to dislodge varioustissue that may adhere to the surface of the catheter or push againstthe catheter from the vessel in which the catheter resides.

In general, in one aspect, the implementation of the disclosurefeatures, a catheter assembly including an elongated main body definingat least two longitudinal lumens including distally positioned openings.At least one side-port defined in the main body communicates with atleast one of the longitudinal lumens. An inflatable balloon is disposedaround a portion of the main body and includes a distal end disposedsubstantially adjacent to a proximal side of the at least one side-port.The inflatable balloon in an inflated state is configured to extend atpartially over the at least one side-port.

One or more of the following features may also be included. Theelongated main body may also define a third lumen configured tofacilitate fluid flow to the inflatable balloon. The third lumen isintegrated in a wall of the elongated main body.

The catheter assembly may include a chamber defined between theinflatable balloon and the elongated main body. The main body defines aninflation-port disposed and configured to place the third lumen in fluidcommunication with the chamber.

The inflatable balloon may be configured for delivery of ananti-restenotic and or anti-thrombogenic agent to an area of a vesselsurrounding the catheter assembly.

In general, in another aspect, the implementation of the disclosure mayfeature a multiple-lumen catheter assembly including an elongated mainbody defining a longitudinal axis and an internal septum extending thelength thereof. The main body and the septum define at least twointernal lumens extending longitudinally along the longitudinal axis,wherein the first and second lumens occupy at least a portion of atraverse cross-section of the main body. The elongated main body alsoincludes at least one side-port in fluid communication with the internallumens. An inflatable balloon is disposed around a portion of theelongated main body which includes a distal end disposed substantiallyadjacent to the at least one side-port. A third lumen is disposed influid communication with the inflatable balloon.

One or more of the following features may also be included. The thirdlumen is disposed within one of the first and second lumens. In otherembodiments, the third lumen is integrated in a wall of the main body.The elongated main body defines an inflation port disposed andconfigured to place the third lumen in fluid communication with achamber defined between the inflation balloon and the elongated mainbody. The inflation lumen may be provided with an end cap adapted tofluidly seal a distal end of the inflation lumen

The inflatable balloon may be configured for delivery of ananti-restenotic or anti-thrombogenic agent to an area of a vesselsurrounding the multiple-lumen catheter assembly.

In general, in another aspect, the implementation of the disclosure mayfeature a method of dislodging tissue from a catheter includingproviding a dialysis catheter having an elongated main body defining alongitudinal axis and having a length along the longitudinal axisbetween a distal end and a proximal end. The elongated main body furtherincludes at least one internal lumen. An inflatable balloon is disposedon an outer surface of the elongated main body and is configured to movefrom a deflated state to an inflated state. The inflatable balloon isinflated to dislodge tissue from the elongated main body.

One or more of the following features may also be included. The catheteralso includes a side-port in fluid communication with the internallumen. The inflatable balloon is disposed adjacent to the side-port andmay be configured to extend at least partially over the side-port whenin the inflated state. The inflatable balloon may be disposed adjacentthe distal end of the elongated main body

The method may also include deflating the inflatable balloon and thenflowing fluid through the internal lumen and out the side-port to removeany tissue dislodged by the inflatable balloon and pushed into theside-port.

The inflatable balloon may be a drug eluting balloon. The drugs elutedby the inflatable balloon may include anti-restenotic agents oranti-thrombogenic agents.

BRIEF DESCRIPTION OF THE DRAWINGS

Objects and features of the presently-disclosed dialysis catheterassembly will become apparent to those of ordinary skill in the art whendescriptions of various embodiments thereof are read with reference tothe accompanying drawings, of which:

FIG. 1 is a top view of an embodiment of a catheter assembly includingan inflatable balloon in accordance with the present disclosure;

FIG. 2 is a top view of another embodiment of a catheter assemblyincluding an inflatable balloon in accordance with the presentdisclosure;

FIG. 3 is an enlarged, cross-sectional view taken along line 3-3 of FIG.1;

FIG. 4 is an enlarged, cross-sectional view similar to FIG. 3, showinganother embodiment of the catheter main body;

FIG. 5 is an enlarged, cross-sectional view taken along line 5-5 of FIG.1;

FIG. 6 is an enlarged, cross-sectional view taken along line 6-6 of FIG.1;

FIGS. 7 and 8 are enlarged, longitudinal cross-sectional views of thearea of detail indicated in FIG. 1 illustrating a distal portion of thecatheter assembly, including the inflatable balloon, during differentstages of operation of the inflatable balloon;

FIG. 9 is an enlarged, cross-sectional view taken along line 9-9 of FIG.2;

FIG. 10 is an enlarged, cross-sectional view taken along line 10-10 ofFIG. 2;

FIG. 11 is an enlarged, cross-sectional view taken along line 11-11 ofFIG. 2;

FIG. 12 is an enlarged, cross-sectional view taken along line 12-12 ofFIG. 2;

FIG. 13 is a partial, perspective view of the catheter main body of thecatheter assembly of FIG. 2;

FIG. 14 is a partial, perspective view similar to FIG. 13, showinganother embodiment of the catheter main body; and

FIGS. 15 and 16 are top, partial, cross-sectional views of the catheterassembly of FIG. 2, including the inflatable balloon, during differentstages of operation of the inflatable balloon.

DETAILED DESCRIPTION

Hereinafter, embodiments of the presently-disclosed dialysis catheterassembly are described with reference to the accompanying drawings. Likereference numerals may refer to similar or identical elements throughoutthe description of the figures. As shown in the drawings and as used inthis description, and as is traditional when referring to relativepositioning on an object, the term “proximal” refers to that portion ofthe device, or component thereof, that is closer to a user, such as aclinician or nurse, and the term “distal” refers to that portion of thedevice, or component thereof, farther from the user.

As it is used in this description, the term “patient” generally refersto a human patient or other animal, and the term “clinician” generallyrefers to a doctor, nurse or other care provider and may include supportpersonnel.

The presently-disclosed catheter assembly embodiments may be applicableto a variety of catheter-related procedures, such as, for example,hemodialysis, cardiac, abdominal, urinary, and intestinal procedures, inchronic and acute applications. Turning now to the drawings andreferring first to FIGS. 1, 3 and 5 through 8, there is shown a catheterassembly 10 in accordance with an embodiment of the present disclosure.Catheter assembly 10 includes an elongated catheter main body 1 and aninflatable balloon 38 disposed around a portion 31 of the catheter mainbody 1. Catheter main body 1 may be made of a synthetic resin, such aspolyurethane, or other material. In some embodiments, the catheter mainbody 1 is formed of a soft elastic material, such as silicone, which mayrequire thicker walls because of the pliability of the silicone.Silicone may be preferred for certain applications because it is inert.Catheter main body 1 may include an internal septum 9 (FIG. 3) extendinglongitudinally along a longitudinal axis “A-A” defined by the cathetermain body 1. Catheter main body 1 may be formed with three lumensextending longitudinally along the longitudinal axis “A-A”, namely, aperfusion lumen 2 to facilitate fluid flow in a first direction, anaspiration lumen 3 to facilitate fluid flow in a second direction (e.g.,opposite to the first direction), and an inflation lumen 4 to facilitatefluid flow into, and out of, the inflatable balloon 38.

Generally, the septum 9 and the walls of the catheter main body 1 formthe perfusion lumen 2 and the aspiration lumen 3. More specifically, asshown in FIG. 3, the perfusion lumen 2 is defined by the perfusion-lumenwall portion 13 and the septum 9, and the aspiration lumen 3 is definedby the aspiration-lumen wall portion 14 and the septum 9. Although theseptum 9 is in the form of a flat strip, which divides the generallyhollow catheter main body 1 into two substantially semi-cylindricallumens, the septum 9 may be formed in various other configurations, suchas a Y-shape forming three lumens.

In some embodiments, the perfusion lumen 2 and the aspiration lumen 3are generally D-shaped in traverse cross-section (i.e., cross-sectiontraverse to the longitudinal axis “A-A”) and have substantially equalcross-sectional areas. In other embodiments, the aspiration lumen (e.g.,103 shown in FIG. 9) may have a larger cross-sectional area than thecross-sectional area of the perfusion lumen (e.g., 102 shown in FIG. 9).The perfusion lumen 2 and the aspiration lumen 3 may terminate atopenings at the distal end of the catheter main body 1. Catheterassembly 10 may include one or more side-ports, such as side-ports 3 a,3 b shown in FIG. 6, defined in the aspiration-lumen wall portion 14and/or one or more side-ports (not shown) defined in the perfusion-lumenwall portion 13. In an alternative embodiment not shown, a dialysiscatheter known to be reversible, such as the PALINDROME™ or theMAHURKAR® Maxid™ catheters, may include a side-port such as shown inFIG. 6 in the catheter main body 1 in both the aspiration-lumen wallportion 14 and the perfusion-lumen wall portion 13.

Inflation lumen 4 (FIG. 3) may have a relatively small cross-sectiontraverse to the longitudinal axis “A-A”, as compared to the traversecross-section of the perfusion lumen 2 and the aspiration lumen 3.Inflation lumen 4 may be integrally formed in the walls of the cathetermain body 1, and may be disposed at the junction of the perfusion-lumenwall portion 13 and the aspiration-lumen wall portion 14. Inflationlumen 4 or portion thereof may additionally, or alternatively, bedisposed within the septum 9. The shape, size and location of theinflation lumen 4 may be varied from the configuration shown in FIG. 3without departing from the scope of the invention.

FIG. 4 illustrates an embodiment of the catheter main body 1 in whichthe inflation lumen 4 is disposed in the perfusion-lumen wall portion13. In some embodiments, such as shown in FIG. 9, the inflation lumen104 may be disposed within one of the two or more lumens 103 defined bythe catheter main body.

To facilitate connection of the catheter assembly 10 to a medicaldevice, e.g., a dialyzer, an injection syringe, or other extracorporealapparatus, a catheter hub 8 of the catheter assembly 10 is provided withextension tubes 5 and 6. Catheter main body 1 includes a proximal end 18and a distal end 19. The proximal end 18 is coupled to the catheter hub8, whereby the perfusion lumen 2 is fluidly coupled to the extensiontube 5 and the aspiration lumen 3 is fluidly coupled to the extensiontube 6. Extension tubes 5 and 6 may be made of flexible synthetic resin,such as silicone or polyurethane, or other suitable material. Extensiontubes 5 and 6 may be provided with clamps 21 and 22, respectively.Clamps 21, 22 are adapted to be movable from an open position to asubstantially closed position to compress a corresponding extension tube5, 6, and thereby inhibit fluid flow through the extension tube 5, 6.Catheter hub 8 may be releasably connected to or integrally formed withthe proximal end 18 of catheter main body 1. Similarly, extension tubes5 and 6 may be releasably connected to or integrally formed with thecatheter hub 8.

Luer adapters 15 and 16 are integrally formed or otherwise associatedwith the ends of the extension tubes 5 and 6, respectively. Lueradapters 15 and 16 are adapted to be connected to a dialysis system at atime of dialysis, whereby the luer adapter 15 is fluidly coupled to theextension tube 5 and disposed in fluid communication with the perfusionlumen 2, and the luer adapter 16 is fluidly coupled to the extensiontube 6 and disposed in fluid communication with the aspiration lumen 3.

Referring to FIG. 5, the catheter main body 1 defines an inflation port44 disposed and configured to place the inflation lumen 4 in fluidcommunication with the inflatable balloon 38. During operation of theinflatable balloon 38, such as, for example, an inflation process tobreak-up or remove stenosis, fluid flow such as saline is supplied (notshown) via the inflation lumen 4 through the inflation-port 44 and intoa chamber 36 of inflatable balloon 38.

FIGS. 7 and 8 show a distal portion 12 of the catheter assembly 10 ofFIG. 1 including the inflatable balloon 38 during different stages ofoperation of the inflatable balloon 38. Inflatable balloon 38 may haveany suitable length “L”. Inflatable balloon 38 includes a first flange37 disposed on the proximal end of the inflatable balloon 38, and asecond flange 39 disposed on the distal end of the inflatable balloon38. The first and second flanges 37, 39 are adapted to facilitateconnection of the inflatable balloon 38 to the walls of the cathetermain body 1. First and second flanges 37, 39 may be connected to thewalls of the catheter main body 1 using any fastening techniqueincluding using an adhesive, sonic welding, or by any other suitableprocess. The connection of the inflatable balloon to the catheter mainbody 1 forms the chamber 36 for receiving the inflation fluid frominflation-port 44.

Inflatable balloon 38 may be disposed substantially adjacent to aproximal side of the side-ports 3 a, 3 b, and may surround any portion(e.g., distal portion 31 shown in FIG. 1) of the catheter main body 1.In other embodiments, the proximal half of the catheter main body 1 maybe surrounded by the inflatable balloon 38, and in other embodiments anyportion of the catheter main body may be surrounded by the inflatableballoon 38.

Inflatable balloon 38 according to various embodiments may be operatedin conjunction with pharmacological intervention to prevent or reducedevelopment of stenosis. Inflatable balloon 38 may be configured as adrug-eluting balloon for delivery of an anti-restenotic agent to an areaof the vessel surrounding the catheter assembly 10 in which stenosis maydevelop. In some embodiments, the inflatable balloon 38 may be atri-lumen percutaneous transluminal angioplasty (PTA) balloon that iscoated with a base polymer layer including either a biostable polymer,such as phosphorylcholine, or a bioabsorbable polymer, such as, forexample, polylactic acid (PLA), polyglycolic acid (PGA), poly-l-lactide(PLLA), their co-polymers, (e.g., PGA/PLA), etc. In some embodiments,the polymer layer may be impregnated with an anti-restenotic agent, suchas, for example, paclitaxel, sirolimus, biolimus, tacrolimus,picrolimus, or any other-limus family member drug. In some embodiments,the polymer and drug elution characteristics may be designed so thatcomplete elution of the drug occurs over about a 28-day time period.Inflatable balloon 38 may additionally, or alternatively, be configuredas a “weeping balloon” with pores that open at relatively highpressures, such as greater than 8 atmospheres.

In an alternative embodiment not shown, the catheter main body 1 mayinclude a plurality of inflation lumens 4 adapted to allow theinflatable balloon 38 to substantially evenly inflate around thecircumference of the catheter main body 1. In such alternativeembodiments, the catheter main body 1 may include multipleinflation-ports 44 adapted to place the inflation lumen 4, or pluralityof inflation lumens 4, of the catheter main body 1 into fluidcommunication with the inflatable balloon 38.

Referring to FIG. 8, the inflatable balloon 38 may be configured topermit expansion thereof in the distal direction (e.g., along thelongitudinal axis “A-A”) to enable at least a distal portion of theinflatable balloon 38 to extend over at least a proximal portion of theside-ports 3 a, 3 b during inflation of the inflatable balloon 38. Theexpansion of the inflatable balloon 38 in the distal direction may actto dislodge and/or move material, such as thromboembolic material, awayfrom, or into, the side-ports 3 a, 3 b. If material is pushed into theside-ports, fluid flow and/or heparin can then be used to clear theside-ports 3 a, 3 b by pressure or chemical reaction. In otherembodiments, the inflatable balloon 38 may not extend over theside-ports 3 a, 3 b, but rather expand to break up any tissue that hasattached to the catheter main body 1, such as thrombus or fibrin sheath.

Turning now to FIGS. 2 and 9 through 16, an embodiment of a catheterassembly 100 is shown including an elongated catheter main body 11 andthe inflatable balloon 38 of FIG. 1 disposed around a distal portion 131of the catheter main body 11. Catheter main body 11 may include one ormore lumens. The catheter main body 11 includes a proximal end 118 and adistal end 119.

Catheter main body 11 includes an internal septum 99 (FIG. 9) extendingalong the length thereof. Septum 99 and the walls of the catheter mainbody 11 form a perfusion lumen 102 and an aspiration lumen 103. Septum99 is located such that the aspiration lumen 103 has a largercross-sectional area than the cross-sectional area of the perfusionlumen 102. Septum 99 of the catheter main body 11 of FIG. 9 is similarto the septum 9 of the catheter main body 1 shown in FIG. 3 (except forits location) and further description thereof is omitted in theinterests of brevity.

Catheter assembly 100 includes an inflation lumen 104 disposed withinthe catheter main body 11. The inflation lumen 104 may have any suitabledimensions, such as diameter and length. In some embodiments, the lengthof the inflation lumen 104 may be different than the length of theperfusion lumen 102 and the aspiration lumen 103. In some embodiments,such as shown in FIG. 14, the perfusion lumen 102, the aspiration lumen103, and the inflation lumen 104 may have substantially the same length.In the embodiment shown in FIG. 14, the distal end of the inflationlumen 104 would be sealed at the distal end to enable the inflationfluid to exert pressure into the inflatable balloon 38.

Referring to FIG. 10, the inflation lumen 104 is coupled to or otherwiseassociated with the aspiration-lumen wall portion 14. Catheter main body11 defines an inflation-port 144 disposed and configured to place theinflation lumen 104 in fluid communication with the inflatable balloon38.

Referring to FIG. 13, the inflation lumen 104 includes a distal end 109.As cooperatively shown in FIGS. 2 and 13, the distal end 109 is disposedwithin the distal portion 131 (FIG. 2) of the catheter main body 11surrounded by the inflatable balloon 38. As best shown in FIGS. 15 and16, the inflation lumen 104 is provided with an end cap 107 adapted tofluidly seal the distal end 109 of the inflation lumen 104. In thisconfiguration, fluid flow (e.g., saline, etc.) supplied via theinflation lumen 104 can be wholly used to operate the inflatable balloon38, which may allow for user-control of operational characteristics ofthe inflatable balloon 38, such as, for example, rate of inflation,inflation volume, and pressure exerted by the inflatable balloon 38 onthe vessel surrounding the catheter main body 11.

To facilitate connection of the catheter assembly 100 to a medicaldevice, such as a dialyzer, an injection syringe, or other apparatus, acatheter hub 88 of the catheter assembly 100 is provided with extensiontubes 5, 6 and 7. Catheter hub 88 may be releasably connected to orintegrally formed with the proximal end 118 of catheter main body 11.Luer adapters 15, 16 and 17 are integrally formed or otherwiseassociated with the ends of the extension tubes 5, 6 and 7,respectively. Extension tube 7 may be provided with a clamp 23 (FIG. 2).Luer adapters 15 and 16 are adapted to be connected to a dialysis systemat a time of dialysis, whereby the luer adapter 15 is fluidly coupled tothe extension tube 5 and disposed in fluid communication with theperfusion lumen 102, the luer adapter 16 is fluidly coupled to theextension tube 6 and disposed in fluid communication with the aspirationlumen 103. The luer adapter 17 is fluidly coupled to the extension tube7 and disposed in fluid communication with the inflation lumen 104.Further description of the extension tubes 5 and 6 of the catheterassembly 100 and other structures, such as clamps 21 and 22, in commonwith the catheter assembly 10 shown in FIG. 1 is omitted in theinterests of brevity.

In either embodiment, inflating the inflatable balloon will enable thebreak-up and/or dislodging of any tissue, such as stenosis, thrombus orfibrin sheath, that may have adhered to the catheter main body 1.Further, inflating the inflatable balloon will compress any stenosisfound on the vessel wall away from the catheter, thereby helping to keepthe blood vessel around the catheter patent. Also, if a drug elutingballoon is utilized, or the balloon is coated with an anti-stenotic oranti-thrombogenic material, as described above, the formation of furtherstenosis or thrombus may be slowed or eliminated, further helping tomaintain blood flow around the catheter. The inflatable balloon may beinflated at any time, including before a dialysis session or in betweendialysis sessions, to help maintain the patency of the catheter.

Although embodiments have been described in detail with reference to theaccompanying drawings for the purpose of illustration and description,it is to be understood that the inventive processes and apparatus arenot to be construed as limited thereby. It will be apparent to those ofordinary skill in the art that various modifications to the foregoingembodiments may be made without departing from the scope of thedisclosure.

What is claimed is:
 1. A dialysis catheter assembly comprising: a hub; afirst and a second extension tube each coupled to the hub; an elongatedmain body having a proximal end and a distal end, the proximal end ofthe elongated main body coupled to the hub, the elongated main bodydefining a first and a second longitudinal lumen and at least oneside-port, the first and second longitudinal lumens in fluidcommunication with respective first and second extension tubes, and theat least one side port in fluid communication with at least one of thefirst and second longitudinal lumens; and a balloon disposed on theelongated main body proximal to and adjacent the at least one side-portwhen the balloon is in an uninflated state, wherein the balloon isinflatable in a distal direction to extend at least partially over theat least one side-port so that the balloon is at least partiallycoextensive with the at least one side-port when the balloon in aninflated state.
 2. The dialysis catheter assembly of claim 1, whereinthe longitudinal lumens extend to a distal end of the elongated mainbody.
 3. The dialysis catheter assembly of claim 1, wherein thelongitudinal lumens are each D-shaped in a transverse cross-section ofthe elongated main body.
 4. A catheter assembly comprising: an elongatedmain body having an internal septum, the elongated main body and theinternal septum defining longitudinal lumens having substantially equalcross-sectional area, the elongated main body defining an inflationlumen, and the elongated main body defining at least one side port influid communication with at least one of the longitudinal lumens; and aballoon disposed on the main body proximal to and adjacent the at leastone side-port when the balloon is in an uninflated state, wherein theballoon is inflatable in a distal direction to extend at least partiallyover the at least one side-port so that the balloon is at leastpartially coextensive with the at least one side-port when the balloonin an inflated state.
 5. The catheter assembly of claim 4, wherein thelongitudinal lumens extend to a distal end of the elongated main body.6. The catheter assembly of claim 4, wherein the longitudinal lumens areeach D-shaped in a transverse cross-section of the elongated main body.7. The catheter assembly of claim 4, wherein a distal end of theinflation lumen is sealed and is proximal to the at least one side-port.8. A catheter assembly comprising: an elongated main body defining aplurality of longitudinal lumens and at least one side-port in fluidcommunication with at least one of the plurality of longitudinal lumens;and a balloon disposed on the main body proximal to and adjacent the atleast one side-port when the balloon is in an uninflated state, whereinthe balloon is inflatable in a distal direction to extend at leastpartially over the at least one side-port so that the balloon is atleast partially coextensive with the at least one side-port when theballoon in an inflated state.
 9. The catheter assembly of claim 8,wherein the balloon comprises a polymer impregnated with ananti-restenotic agent.
 10. The catheter assembly of claim 8, furthercomprising a septum disposed in the main body such that the septum andthe main body define at least two of the plurality of longitudinallumens.
 11. The catheter assembly of claim 8, wherein the elongated mainbody defines a plurality of side ports each having the same shape. 12.The catheter assembly of claim 8, wherein the balloon is coupled to themain body at a first flange and a second flange, the second flange isdistal to the first flange, and the balloon is inflatable to expanddistal to the second flange.
 13. The catheter assembly of claim 12,wherein the balloon is inflatable to remain distal to the first flange.14. The catheter assembly of claim 8, wherein the plurality oflongitudinal lumens includes an inflation lumen in fluid communicationwith the inflatable balloon, the inflation lumen terminating proximal tothe at least one side-port.
 15. The catheter assembly of claim 14,wherein the plurality of longitudinal lumens further includes anaspiration lumen and a perfusion lumen, the aspiration lumen and theperfusion lumen each extending distal to the inflation lumen.
 16. Thecatheter assembly of claim 15, wherein the aspiration lumen and theperfusion lumen each extend to the distal end of the main body.
 17. Thecatheter assembly of claim 15, wherein the aspiration lumen and theperfusion lumen are each D-shaped in a transverse cross-section of theelongated main body and have substantially equal cross-sectional areas.